Team Horizon is seeking a Senior Product QA Manager & QP to join our clients team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Why you should apply: This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of QA tasks. Conduct internal/external audits and participate in regulatory/customer inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies. Review and approve Product Quality Reviews (PQRs) and track finished product data. Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics. Act as Designee for the Quality Director when required. Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making. What you need to apply: MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC). Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments. Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities. Results-driven mindset with proven prioritization skills and commitment to quality. High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills. Skills: Regalutory Quality Assurance Quality Management GMP Benefits: Medical Aid / Health Care Parking Pension Fund Performance Bonus Annual Bonus / 13th Cheque
Project Engineer (Syringe Inspection) Team Horizon is seeking a Project Engineer (Syringe Inspection) for a client in Dublin who will support the installation, validation, and lifecycle management of automated syringe inspection systems within a GMP fill-finish facility expansion. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives. Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Act as System Owner (SO) for automated syringe inspection systems. Serve as SO during the FAT/SAT, commissioning, qualification, and validation activities. Ensure compliance with GMP, Annex 1, and data integrity requirements. Own system performance metrics including: False reject rates, Detection capability, OEE performance. Support inspection recipe development and optimisation. Develop maintenance and lifecycle strategies for inspection equipment. Lead troubleshooting and root cause investigations for inspection failures. Support audit readiness and regulatory inspections. What you need to apply: Bachelor’s Degree in Engineering (Mechanical, Electrical, Automation, or related discipline). 5+ years’ experience in biopharmaceutical manufacturing. Experience with Automated visual inspection systems (AVI), Vision systems, High-speed packaging or inspection lines. Understanding of particulate detection, cosmetic defect inspection, and container closure integrity. Experience supporting equipment validation and data integrity compliance. Strong analytical and problem-solving skills. #J-18808-Ljbffr
A leading biopharmaceutical company in Dublin is seeking a Project Engineer (Syringe Inspection) to support the installation and lifecycle management of automated inspection systems. This role involves compliance with GMP standards, system performance monitoring, troubleshooting, and project leadership. The ideal candidate holds a Bachelor’s Degree in Engineering with over 5 years of biopharmaceutical experience and a solid understanding of automated visual inspection systems. Join a team working towards improving health outcomes for patients globally. #J-18808-Ljbffr
Team Horizon is seeking a Senior Product QA Manager & QP to join our clients team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Why you should apply: This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of QA tasks. Conduct internal/external audits and participate in regulatory/customer inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies. Review and approve Product Quality Reviews (PQRs) and track finished product data. Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics. Act as Designee for the Quality Director when required. Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making. What you need to apply: MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC). Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments. Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities. Results-driven mindset with proven prioritization skills and commitment to quality. High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills. Skills: Regalutory Quality Assurance Quality Management GMP Benefits: Medical Aid / Health Care Parking Pension Fund Performance Bonus Annual Bonus / 13th Cheque
A safety consultancy firm is seeking a Fire Prevention Officer in Cork. The role involves advising on equipment suitability, conducting regular inspections, and coordinating emergency plans. Candidates should have a HETAC level 7 qualification in engineering, fire engineering, or related fields, along with two years of relevant experience. Proficiency in Microsoft Office is essential, and the position emphasizes a collaborative culture with a focus on safety management within the organization. #J-18808-Ljbffr
A leading manufacturing company in Sligo is in search of a Quality Technician to join their Quality Team. The successful candidate will ensure quality goals are met by conducting incoming product testing, managing quality documentation, and participating in continuous improvement initiatives. A third-level qualification in a relevant field and experience in a GMP environment are preferred. This position provides a great opportunity to work in a people-focused culture that embraces diversity and inclusion. #J-18808-Ljbffr
Facilities Technician Team Horizon is seeking a Facilities Technician for a client in Enniscorthy. This person will perform preventative maintenance on equipment and troubleshoot problems. Repair equipment and systems when they break and must document everything actioned. Why you should apply: Join inspiring leaders and passionate colleagues committed to creating an inclusive, growth-focused, and rewarding workplace culture. Enjoy outstanding career development and progression opportunities. Highly competitive salary along with an excellent benefits package. What you will be doing: Conduct work on Electrical systems, BMS Systems, HVAC, Boiler Control Systems and emergency lighting systems and process / manufacturing equipment. Complete work on building services including Mechanical, Electrical, Fire Systems, Building Fabric, etc. Conduct Mechanical and Electrical maintenance including fault finding. Completion of facility repair work (General day to day facility maintenance and repairs) Liaise with supplier and contract companies to ensure maintenance and calibration activities are completed on time. Ensure all contractors on site are compliant with onsite Health and Safety and GMP standards and procedures. Participate on project teams with engineers, technicians and other professionals of various disciplines/departments to continuously improve our manufacturing environments and processes. Support facility validations and manufacturing area qualifications as required. Manage the CMMS system for all facilities and utilities assets and instruments Update the plant calibration and preventative maintenance schedules as required for new equipment or updates on existing equipment Other Responsibilities may include, however are not limited to: Support other functions in software validation of equipment controls such as Building management systems, facility controls, process equipment controls, HR administrative systems etc. What you need to apply: Successful completed a Trade’s Certificate or qualified in a technical discipline. Fundamental understanding of mechanical, electrical and other utility systems. Up to 2 years Electrical & HVAC facilities experience, with high levels of flexibility and innovation. Experience in Facility Equipment fault finding and maintenance activities. Knowledge of Electrical systems, BMS Systems, HVAC, Boilers, Boiler Control Systems and emergency lighting systems. Experience in building services (Mechanical, Electrical, Fire Systems, Building Fabric, etc) Excellent interpersonal skills and self-motivated. Excellent report writing and PC literate. Cleanroom experience is an advantage but not essential. Ability to assess urgency and impact (e.g., safety-critical vs. routine maintenance). #J-18808-Ljbffr
A leading technical staffing firm is seeking a Facilities Technician in Wexford. In this role, you will perform preventative maintenance, troubleshoot issues, and manage facility system repairs including HVAC and electrical systems. The ideal candidate will hold a Trade's Certificate and have up to 2 years of relevant experience. This position offers excellent career development opportunities and a competitive salary within an inclusive workplace culture. #J-18808-Ljbffr
Team Horizon is seeking a Engineering Technician for a leading manufacturing company in Sligo. To work as a team member to support Moulding/Tooling, Assembly in line with all safety, regulatory and organizational requirements. Why you should apply: You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success. They put their people first and live their diversity and inclusion values embracing all perspectives. What you will be doing: Advance performance of site through Key Performance Indicators and metrics. Partner with Operations to ensure daily production is met. Responsible to be Subject Matter Expert on routine maintenance of all areas of responsibility regarding equipment and process. Interface and work with equipment vendors as required for detailed issue resolution. Embrace and drive the site Maintenance Excellence Programme. Fabrication of ad hoc mechanical and electrical parts to ensure efficient repairs, upgrades, maintenance. Participating in project teams and completing assigned projects/tasks. Providing technical support to operations to ensure production schedule is achieved including optimization of moulding and assembly process. Providing technical support to operational and strategic projects when required. Documentation of all activities in line with cGMP requirements. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Execution of routine manufacturing documentation, commissioning and validation protocols on an ongoing basis. Providing an efficient maintenance service to include Moulds/ Moulding M/C’s, Assembly and Test Equipment. Perform equipment Calibration per procedural requirements. Updating the Maintenance and Calibration systems and ensuring compliance. Interpreting electrical and mechanical drawings for decision making and improvements. Troubleshooting and resolution of day-to-day technical issues in: Injection mould machine and tooling – Equipment, Process, Electrical/Mechanical tasks. Assembly (automatic and semi-automatic) Equipment, Process, Electrical/Mechanical process, control systems. Maintaining the overall cGMP of the production areas. Execution of all work utilizing Maximo management system. Any other duties as assigned. What you need to apply: Leaving Cert OR Sr. Level Trade Certificate OR Technical FETAC 6 from Level 3 institute or commitment to obtain same. Experience in following technical area: o Mold Tooling o Electrical o Automation Demonstrated computer skills such as: o Operating Computer interfaced equipment. Interfacing with ERP systems. Minimum of 3 years in a high precision manufacturing industry post qualification Proven problem-solving ability on complex equipment. Minimum 2 year of experience in regulated manufacturing environment required. Requires proven problem-solving skills under the pressure. The position requires detailed evaluation of a number of viable solutions to each problem. #J-18808-Ljbffr
Team Horizon is seeking Maintenance Technicians for a leading pharmaceutical companies in Blanchardstown, Dublin. This role involves shift work on a 4 week cycle. Responsible for the set up and maintenance of automated vial and syringe filling equipment. Responsible for maintenance and repair of plant equipment and utilities. Why you should apply: Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work. You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin What you will be doing: Responsible for Setup, planned maintenance and fault finding of automated Vial and Syringe filling equipment. Responsible for maintenance of equipment and utilities and documenting work to a GMP standard. Manage external contractors when required during equipment installations and planned service visits. Manage spare parts, consumables, and services to keep equipment schedules compliant. Develop, Implement, and promote a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with department management, the Engineering dept reliability engineer and the Production department utilizing tools such as Trend’s analysis & Control charts & Data review. Support the creation and modification of documentation to support maintenance and calibration activities (PM, Data Sheets, Work Instructions, troubleshooting guides). Support compliance efforts related to Safety Events, Quality Events, CAPAs, change management and investigations and assist in the investigation and resolution of electrical and mechanical issues on equipment. Ensure maintenance routines, procedures, and work plans are developed to the necessary standards and best practice to ensure compliance with cGMP and EHS regulations. Comply with cGMP & EHS requirements from a local, global, and regulatory perspective. You will be required to be flexible in this position and must be prepared to such undertake overtime; shift cover, on call and other works as may be assigned to your role by the company. All other duties as requested or assigned. What you need to apply: Minimum of a Certification in Electrical/Mechanical Engineering and a minimum of 5 years relevant experience. However, a combination of experience and education will be taken into consideration. Excellent Interpersonal / Communication skills Conflict management / Negotiation. Structured decision making. Computer literacy (Word, Excel, PM systems). Report preparation & presentation. Ability to manage multiple projects and activities simultaneously. Proven analytical and problem-solving skills. Ability to read and interpret general business documents and to compile Technical reports. Ability to work with peers and communicate. #J-18808-Ljbffr
